20/20 Launching First COVID-19 Rapid Antibody Test Authorized by FDA for Point-of-Care Use

Fingerstick Blood Test w/ Results in Minutes Now Available to Pharmacies and Medical Centers Nationwide

ROCKVILLE, Md.–(BUSINESS WIRE)–20/20 BioResponse, a business unit of 20/20 GeneSystems, Inc., announced today that it is now accepting orders for the Assure COVID-19 IgG/IgM Rapid Test kits. These kits were the first to receive an emergency use authorization (EUA) from the FDA for point-of-care (POC) use with fingerstick blood samples on September 23. According to the FDA announcement “this authorization means that fingerstick blood samples can now be tested in POC settings like doctor’s offices, hospitals, urgent care centers and emergency rooms rather than having to be sent to a central lab for testing.” “Authorizing POC serology tests will enable more timely and convenient results for individuals who want to understand if they have previously been infected with the virus that causes COVID-19,” said FDA Commissioner Stephen M. Hahn, M.D.

The company is now accepting orders from pharmacies, urgent care centers, and doctor’s offices, especially those servicing first responders.

The test kits are rapid chromatographic immunoassays (configured like a home pregnancy test) to detect IgM and IgG antibodies to COVID-19 SARS-CoV-2 in blood, which is the cause of COVID-19. IgM antibody generally begins to rise within 1 week of initial infection and IgG typically appears about 14 days after infection.

“As vaccines begin to enter the market over the coming months, we believe there will be increasing demand by individuals and their healthcare providers for antibody tests,” said Michael Lebowitz, Ph.D., 20/20’s Chief Scientific Officer. “The presence of serum antibodies against an infectious agent may be an indicator of immunity against said agent. Until such time as the durability of the immune response is established, it will be important for both those who have had a prior infection as well as those who have received a vaccine to be monitored on a regular basis for the presence of antibodies. Such information can be used to suggest that an individual may benefit from a boost with the vaccine”.

20/20 also plans to conduct studies to validate the use of an at-home fingerstick blood collection device together with a quantitative antibody test awaiting an EUA from the FDA. Quantitative tests permit individuals to monitor changes in their antibody levels over time and may help assess susceptibility to future infections. The company, which specializes in developing machine learning algorithms associated with laboratory tests, will seek to build algorithms to help predict and quantify the strength and durability of immune response.

Please refer to www.CoronaCheckTest.com for product details, updates, and ordering information.

About 20/20 GeneSystems:

20/20 GeneSystems, Inc. (www.2020Gene.com) is a Rockville, MD based company focused on innovative diagnostics and detection products. In addition to the company’s blood tests for early cancer detection (www.OneTestforCancer.com), 20/20 has also commercialized its patented BioCheck® detection kit to help fire departments and other emergency response organizations screen suspicious powders. (www.BioCheckInfo.com).

Important Notice Regarding Our Regulation A Offering and Forward-Looking Statements

20/20 is offering securities under a qualified offering statement. You may obtain a copy of the offering circular that is part of that offering statement through this link. For more information about 20/20’s securities offering visit https://www.seedinvest.com/2020.genesystems/series.c.

The information set forth in this document includes statements, estimates and projections with respect to our anticipated future performance and other forward-looking statements, which are subject to risks, uncertainties and assumptions. In some cases, you can identify these statements by forward-looking words such as “may”, “might”, “will”, “should”, “expect”, “plan”, “anticipate”, “believe”, “estimate”, “predict”, “potential”, “future” or “continue”, the negative of these terms and other comparable terminology. Such forward-looking statements are based on current plans, estimates and expectations and are made pursuant to the Private Securities Litigation Reform Act of 1995. These statements, estimates and projections are based upon various assumptions that we made concerning our anticipated results and industry trends, which may or may not occur. We are not making any representations as to the accuracy of these statements, estimates or projections. Our actual performance may be materially different from the statements, estimates or projections set forth below based upon a number of factors, including those contained in the Risk Factor section of the offering circular described above. We are under no duty to update any of these forward-looking statements to conform them to actual results or revised expectations.

20/20 is offering securities using an Offering Statement that has been qualified by the Securities and Exchange Commission under Regulation A. The Offering Statement may be downloaded at the 20/20 offering page at the equity crowdfunding portal https://www.seedinvest.com/2020.genesystems/series.c.

Contacts

Ron Baker

20/20 BioResponse

Phone: 301-785-5185

ron@BioCheckInfo.com